Investigation of a Polyphenol-rich Preparation as Support for Oncology Patients Undergoing Gastrointestinal Tumor Resection

Not Applicable

Recruiting

• Conditions: Immunomodulation
• Interventions: Dietary Supplement: Nutridrink Skin Repair; Dietary Supplement: Nutridrink Skin Repair with a mixture of plant extracts rich in polyphenolic compounds

• Registration Number: NCT06017661
• Lead Sponsor: AronPharma Sp. z o. o.

Brief Summary

The aim of the study is to demonstrate, under clinical conditions, the effectiveness of the standard product 'Nutridrink' enriched with a mixture of plant extracts rich in polyphenolic compounds in the aspect of supporting the recovery of oncology patients undergoing surgical resection of tumours.

Detailed Description

Oncology patients undergoing the procedure are exposed to various postoperative complications. Nutridrink with a mixture of extracts with anti-inflammatory and antioxidative properties aims to provide the patient with essential nutrients and bioactive substances that can reduce the inflammatory state, protect cells from oxidative damage, and decrease the risk of complications while supporting tissue healing processes after the surgical procedure. The study group are oncology patients undergoing surgical resection of gastrointestinal tumour. During the study, the effects of the mixture on levels of oxidative stress and inflammation markers will be assessed, as well as the subjective evaluation of patients' quality of life and well-being after surgical surgical tumor resection.

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-24
• Study First Submitted QC: 2023-08-24
• Study First Posted: 2023-08-30
• Study Start: 2023-09-01
• Last Update Submitted: 2023-09-28
• Last Update Posted: 2023-09-29
• Primary Completion: 2023-12-15
• Study Completion: 2023-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Women and men, 18-80 years old
• Patients diagnosed with resectable gastrointestinal tract cancer undergo the resection procedure no later than one month after being enrolled in the study
• Signed informed consent

Exclusion Criteria

• Intake of supplements containing plant extracts, polyphenols or anthocyanins
• Participation in another clinical trial
• Inability to consume the investigational product in liquid form as medication/placebo
• Women who are pregnant, planning to become pregnant during the study or breastfeeding
• Autoimmune disease, severe liver dysfunction, inflammatory bowel disease, tuberculosis, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplantation
• Hypersensitivity/allergy to any of the ingredient

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutridrink Skin Repair	Nutridrink Skin Repair	Group of 15 patients undergoing surgical resection of tumour
Nutridrink Skin Repair with a mixture of plant extracts rich in polyphenolic compounds	Nutridrink Skin Repair with a mixture of plant extracts rich in polyphenolic compounds	Group of 15 patients undergoing surgical resection of tumour

Primary Outcome Measures

Name	Time	Method
GSH level	Baseline, 3 weeks, 6 weeks	Comparison of GSH level
SOD level	Baseline, 3 weeks, 6 weeks	Comparison of SOD level
IL-6 level	Baseline, 3 weeks, 6 weeks	Comparison of IL-6 level
IL-8 level	Baseline, 3 weeks, 6 weeks	Comparison of IL-8 level

Secondary Outcome Measures

Name	Time	Method
Patients' quality of life	Baseline, 3 weeks, 6 weeks	Subjective assessment of patients' quality of life after surgical resection of the tumor (questionnaire). Higher scores mean a better outcome.

Trial Locations

Locations (1)

Uniwersyteckie Centrum Kliniczne, Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólne; 🇵🇱 Gdańsk, Poland